Field of the Invention
The invention relates generally to cranial closure improvements and more specifically to devices and methods used to improve cranial healing and reconstruction and the decrease in patient discomfort and/or palpable or visible deformities often present after a craniotomy.
Background Information
Craniotomy is a common operation in the United States. It is performed for a variety of indications, including head trauma, aneurysm repair, and tumor removal, among others. Most craniotomies are performed by drilling one or more bur holes in the skull down to the level of the dura covering the brain and connecting them with a routing bit on a high-speed drill. The bit pulverizes a tract of bone typically two or more millimeters wide. The space left between the bone edges is called the kerf. At the time of closure, the bone flap is replaced with plates and screws, a specialized compressible closure device, wires, or sutures. All of these present methods leave a gap (shown in FIG. 1) which is either centered (FIG. 1a) or eccentric (FIG. 1b). Current cranial plates, bur hole covers and screw systems are mainly if not entirely affixed on the outer surface of the cranium resulting in palpable and often visible protrusions which provide discomfort if in a place where the scalp moves against the protrusions regularly. Because many craniotomies are performed below the hairline, this often results in gross external deformity. Even for craniotomies located off of the forehead, the palpable or visible deformity (particularly for patients who do not have covering hair) and/or accompanying discomfort from the rubbing is often distressing to the patient.
Unfortunately, a suitable device for assisting cranial reconstruction and decreasing cranial deformities and discomfort has not yet been described. Thus, a need exists for methods and devices capable of assisting the surgeon with improved clinical and procedural outcomes when performing craniotomies.